BACKGROUND Excessive weight gain among young adult women age 18-45 years is an alarming and overlooked trend that must be addressed to reverse the epidemics of obesity and chronic disease. During this vulnerable period, women tend to gain disproportionally large amounts of weight compared to men and to other life periods. Healthy Eating and Active Living Taught at Home (HEALTH) is a lifestyle modification intervention developed in partnership with Parents as Teachers (PAT), a national home visiting, community-based organization with significant reach in this population. HEALTH prevented weight gain, promoted sustained weight loss, and reduced waist circumference. PAT provides parent-child education and services free of charge to nearly 170,000 families through up to 25 free home visits per year until the child enters kindergarten. METHODS This study extends effectiveness findings with a pragmatic cluster randomized controlled trial to evaluate dissemination and implementation (D&I) of HEALTH across three levels (mother, parent educator, PAT site). The trial will evaluate the effect of HEALTH and the HEALTH training curriculum (implementation strategy) on weight among mothers with overweight and obesity across the USA (N = 252 HEALTH; N = 252 usual care). Parent educators from 28 existing PAT sites (14 HEALTH, 14 usual care) will receive the HEALTH training curriculum through PAT National Center, using PAT's existing training infrastructure, as a continuing education opportunity. An extensive evaluation, guided by RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), will determine implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, and adaptation) at the parent educator level. The Conceptual Framework for Implementation Research will characterize determinants that influence HEALTH D&I at three levels: mother, parent educator, and PAT site to enhance external validity (reach and maintenance). DISCUSSION Embedding intervention content within existing delivery channels can help expand the reach of evidence-based interventions. Interventions, which have been adapted, can still be effective even if the effect is reduced and can still achieve population impact by reaching a broader set of the population. The current study will build on this to test not only the effectiveness of HEALTH in real-world PAT implementation nationwide, but also elements critical to D&I, implementation outcomes, and the context for implementation. TRIAL REGISTRATION https://ClinicalTrials.gov , NCT03758638 . Registered 29 November 2018.

中文翻译：

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在国家组织中传播和实施针对母亲的基于生活方式的健康体重计划：一项整群随机试验的研究方案。

背景技术年龄在18-45岁的成年女性中过多的体重增加是一个令人震惊且被忽视的趋势，必须扭转肥胖和慢性病的流行。在这个脆弱的时期，与男性和其他人生阶段相比，女性往往会大量增加体重。“健康饮食和在家教积极生活（HEALTH）”是与“家长当教师”（PAT）合作开发的一种生活方式改变干预措施，这是一个全国性的家庭探访，社区组织，在这一人群中有很广泛的影响。健康防止体重增加，促进持续的体重减轻，并减少腰围。PAT每年通过多达25次免费的家访为近170,000个家庭免费提供亲子教育和服务，直到孩子进入幼儿园为止。方法本研究通过一项实用的整群随机对照试验来扩展有效性研究结果，以评估健康的传播和实施（D＆I）跨三个级别（母亲，家长教育者，PAT场所）。该试验将评估健康和健康培训课程（实施策略）对美国超重和肥胖母亲体重的影响（N = 252健康； N = 252常规护理）。来自28个现有PAT站点（14个健康，14个常规护理）的家长教育者将使用PAT现有的培训基础设施，通过PAT国家中心接受“健康”培训课程。在RE-AIM（达到，有效性，采用，实施，维护）的指导下进行的广泛评估将确定实施结果（可接受性，采用，适当性，可行性，保真度和适应性）。实施研究的概念框架将在三个层面上描述影响健康D＆I的决定因素：母亲，父母教育者和PAT站点，以增强外部有效性（覆盖和维持）。讨论在现有的交付渠道中嵌入干预内容可以帮助扩大基于证据的干预的范围。经过调整的干预措施即使效果降低了也仍然有效，并且仍然可以通过覆盖更广泛的人群来实现对人群的影响。当前的研究将以此为基础，不仅测试健康在全国范围内实际实施PAT的有效性，而且还将测试对D＆I，实施成果和实施背景至关重要的要素。试用注册https：//ClinicalTrials.gov，NCT03758638。2018年11月29日注册。